MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC./ CARTIVA, INC. CARTIVA GREAT TOE IMPLANT; PROSTHESIS, METATARSOPHALANGEAL, JOINT CARTILAGA REPLACEMENT IMPLANT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 02/08/2019

Event Type  malfunction  

Event Description

I was diagnosed with bone on bone osteoarthritis in my right big toe in (b)(6) 2018.My doctor recommended a cartiva implant.I had the device put in on (b)(6) 2019.I had physical therapy, but the post surgery pain never fully went away.On (b)(6) 2019 i went to another doctor to get an opinion on why i still had pain.He took an x-ray and the cartiva implant had fully recessed into the bone.I was back to bone on bone in my toe.On (b)(6) 2019 i had the cartiva implant removed and replaced with an integra silicone toe replacement system.I'm hoping the integra device works better.My doctor told me he has had several other patients that had the cartiva implant completely recede into the bone and he will no longer use the device.There is no mention in their literature about the possibility of receding into the bone.I personally feel this device is dangerous and should be removed from the market.Do you have a picture of the product? yes.Fda safety report id # (b)(4).

• Brand Name: CARTIVA GREAT TOE IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL, JOINT CARTILAGA REPLACEMENT IMPLANT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC./ CARTIVA, INC.
• MDR Report Key: 8861090
• MDR Text Key: 153408893
• Report Number: MW5088738
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 82